Drug · FAERS side-effect profile with label screen
Cenobamate side effects: what 8,296 FDA adverse event reports show
Drug class
Sodium Channel Antagonists, GABA A Receptor Positive Modulators
FDA label (mechanism-of-action class)
Brand names
Xcopri, Xcopri Maintenance Pack, Xcopri Titration Pack
openFDA label
Who reports
8,296 reports · 38% serious · 197 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
XCOPRI is indicated for the treatment of partial-onset seizures in adult patients. XCOPRI is indicated for the treatment of partial-onset seizures in adult patients. ( 1 )
FDA label, Indications and Usage
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 4Labeled (related wording) 5Likely indication confounding 8Reporting / coding artifact 5Lab value / disease marker 1Not in label — unassessed 17
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 766 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Pneumonitis aspiration | 32 | 265.1 184.2–381.4ROR 266.1 · χ² 7,373 / p <1e-300 | 209.8 EB05 155.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 100% (drug 56%) · 100% clinician | no trial data cached |
| Seizure cluster | 63 | 214.9 166.3–277.7ROR 216.5 · χ² 12,152 / p <1e-300 | 186.8 EB05 151.2 · IC025 +5.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=40 | no trial data cached |
| Vagal nerve stimulator implantation | 23 | 212.4 138.8–324.9ROR 213.0 · χ² 4,267 / p <1e-300 | 168.6 EB05 118.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Aura | 112 | 162.0 134.0–195.9ROR 164.2 · χ² 16,676 / p <1e-300 | 148.4 EB05 126.7 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=37 · 86% consumer | no trial data cached |
| Drug titration error | 101 | 102.7 84.2–125.1ROR 103.9 · χ² 9,669 / p <1e-300 | 96.9 EB05 82.0 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious n=32 · 76% consumer | no trial data cached |
| Atonic seizures | 27 | 88.6 60.4–129.9ROR 88.9 · χ² 2,174 / p <1e-300 | 80.8 EB05 58.3 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=18 · 70% consumer | no trial data cached |
| Focal dyscognitive seizures | 38 | 86.9 62.9–120.0ROR 87.3 · χ² 3,036 / p <1e-300 | 80.7 EB05 61.4 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 | no trial data cached |
| Change in seizure presentation | 19 | 75.3 47.7–118.8ROR 75.5 · χ² 1,281 / p 7e-281 | 68.3 EB05 46.2 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | no trial data cached |
| Sudden unexplained death in epilepsy | 15 | 72.1 43.1–120.3ROR 72.2 · χ² 954 / p 1e-209 | 64.6 EB05 41.5 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Partial seizures | 126 | 63.3 53.1–75.4ROR 64.2 · χ² 7,473 / p <1e-300 | 61.2 EB05 52.7 · IC025 +5.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=68 | no trial data cached |
| Multiple-drug resistance | 72 | 60.2 47.7–76.0ROR 60.7 · χ² 4,036 / p <1e-300 | 57.9 EB05 47.6 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=59 · 100% clinician | no trial data cached |
| Petit mal epilepsy | 114 | 57.9 48.2–69.7ROR 58.7 · χ² 6,181 / p <1e-300 | 56.2 EB05 48.0 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=64 | no trial data cached |
| Seizure | 2,450 | 55.1 53.3–57.0ROR 77.8 · χ² 128,042 / p <1e-300 | 53.9 EB05 52.2 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 40.7 · 72% consumer | no trial data cached |
| Tonic convulsion | 29 | 53.4 37.0–77.0ROR 53.5 · χ² 1,408 / p <1e-300 | 50.6 EB05 37.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Brain operation | 33 | 37.5 26.6–52.9ROR 37.7 · χ² 1,120 / p 7e-246 | 36.3 EB05 27.0 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=31 · 85% consumer | no trial data cached |
| Generalised tonic-clonic seizure | 213 | 33.3 29.2–38.1ROR 34.2 · χ² 6,564 / p <1e-300 | 32.8 EB05 29.3 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 33.5 · ♀ 78% (drug 56%) | no trial data cached |
| Psychogenic seizure | 12 | 33.3 18.8–58.8ROR 33.3 · χ² 340 / p 4e-76 | 31.4 EB05 19.1 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | no trial data cached |
| Myoclonic epilepsy | 18 | 31.3 19.6–49.7ROR 31.3 · χ² 491 / p 4e-109 | 30.0 EB05 20.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Product packaging difficult to open | 29 | 30.0 20.8–43.2ROR 30.1 · χ² 775 / p 7e-171 | 29.2 EB05 21.3 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=5 · 100% consumer | no trial data cached |
| Slow speech | 25 | 26.6 17.9–39.4ROR 26.7 · χ² 584 / p 3e-129 | 25.9 EB05 18.4 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=13 · 80% consumer | no trial data cached |
| Postictal state | 10 | 24.7 13.2–46.0ROR 24.7 · χ² 202 / p 4e-46 | 23.2 EB05 13.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Skull fracture | 15 | 23.5 14.1–39.0ROR 23.5 · χ² 298 / p 5e-67 | 22.6 EB05 14.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Gastrostomy | 14 | 23.2 13.7–39.3ROR 23.3 · χ² 273 / p 1e-61 | 22.3 EB05 13.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Thrombocytosis | 32 | 22.3 15.8–31.6ROR 22.4 · χ² 626 / p 2e-138 | 21.9 EB05 16.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 100% (drug 56%) · 100% clinician | no trial data cached |
| Feeling drunk | 60 | 20.5 15.9–26.4ROR 20.6 · χ² 1,084 / p 5e-238 | 20.2 EB05 16.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=24 · 80% consumer | no trial data cached |
| Behaviour disorder | 37 | 17.7 12.8–24.5ROR 17.8 · χ² 564 / p 6e-125 | 17.4 EB05 13.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Drug dose titration not performed | 12 | 17.7 10.0–31.3ROR 17.7 · χ² 172 / p 1e-39 | 16.6 EB05 9.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial data cached |
| Paradoxical drug reaction | 25 | 17.3 11.7–25.7ROR 17.4 · χ² 366 / p 8e-82 | 16.9 EB05 11.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 56%) · 100% clinician | no trial data cached |
| Coma scale abnormal | 19 | 16.9 10.8–26.5ROR 16.9 · χ² 266 / p 3e-60 | 16.3 EB05 10.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Ataxia | 78 | 16.6 13.3–20.8ROR 16.8 · χ² 1,125 / p 7e-247 | 16.5 EB05 13.6 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.3 · ♀ 22% (drug 56%) | no trial data cached |
| Product dose omission issue | 1,837 | 16.4 15.8–17.1ROR 20.8 · χ² 26,755 / p <1e-300 | 16.3 EB05 15.7 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 18.8 · 87% consumer | no trial data cached |
| Diplopia (double vision) | 163 | 16.0 13.7–18.6ROR 16.3 · χ² 2,258 / p <1e-300 | 15.8 EB05 13.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.5 · ♀ 13% (drug 56%) | no trial data cached |
| Loss of employment | 18 | 15.0 9.4–23.8ROR 15.0 · χ² 220 / p 4e-50 | 14.3 EB05 9.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Hypersomnia | 169 | 15.0 12.9–17.4ROR 15.3 · χ² 2,185 / p <1e-300 | 14.9 EB05 13.1 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.6 · 74% consumer | no trial data cached |
| Staring | 14 | 14.8 8.7–24.9ROR 14.8 · χ² 165 / p 4e-38 | 13.6 EB05 7.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Status epilepticus | 65 | 14.6 11.4–18.6ROR 14.7 · χ² 805 / p 2e-177 | 14.4 EB05 11.6 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.3 · ♀ 32% (drug 56%) | no trial data cached |
| Electroencephalogram abnormal | 17 | 13.7 8.5–22.0ROR 13.7 · χ² 186 / p 1e-42 | 12.7 EB05 7.8 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious n=16 | no trial data cached |
| Sleep deficit | 11 | 13.5 7.5–24.5ROR 13.5 · χ² 115 / p 4e-27 | 11.8 EB05 6.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Gastrointestinal tube insertion | 13 | 13.2 7.7–22.8ROR 13.2 · χ² 134 / p 3e-31 | 11.8 EB05 6.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Psychomotor skills impaired | 12 | 11.6 6.6–20.4ROR 11.6 · χ² 105 / p 5e-25 | 9.8 EB05 5.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Seizure | 2,450 | 55.1 53.3–57.0ROR 77.8 · χ² 128,042 / p <1e-300 | 53.9 EB05 52.2 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 40.7 · 72% consumer | no trial data cached |
| Product dose omission issue | 1,837 | 16.4 15.8–17.1ROR 20.8 · χ² 26,755 / p <1e-300 | 16.3 EB05 15.7 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 18.8 · 87% consumer | no trial data cached |
| Fatigue (tiredness) | 831 | 2.7 2.5–2.9ROR 2.9 · χ² 925 / p 2e-203 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · 74% consumer | no trial data cached |
| Somnolence (drowsiness) | 807 | 10.2 9.5–10.9ROR 11.2 · χ² 6,711 / p <1e-300 | 10.1 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 | no trial data cached |
| Off label use (used outside approved label) | 658 | 1.9 1.8–2.1ROR 2.0 · χ² 300 / p 2e-67 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.2 | no trial data cached |
| Dizziness | 653 | 3.3 3.1–3.6ROR 3.5 · χ² 1,080 / p 4e-237 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Product use issue | 599 | 8.1 7.5–8.8ROR 8.7 · χ² 3,755 / p <1e-300 | 8.1 EB05 7.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 86% consumer | no trial data cached |
| Fall | 458 | 3.5 3.2–3.8ROR 3.6 · χ² 821 / p 7e-181 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Headache | 380 | 1.5 1.4–1.7ROR 1.6 · χ² 72 / p 9e-18 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.5 · 78% consumer | no trial data cached |
| Wrong technique in product usage process | 376 | 4.7 4.3–5.2ROR 4.9 · χ² 1,105 / p 2e-242 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 12.5 · 77% consumer | no trial data cached |
| Drug interaction | 354 | 5.6 5.1–6.3ROR 5.9 · χ² 1,357 / p 2e-297 | 5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Drug ineffective (drug did not work) | 351 | 0.7 0.6–0.7ROR 0.7 · χ² 59 / p 9e-15 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Feeling abnormal | 297 | 3.1 2.8–3.5ROR 3.2 · χ² 431 / p 5e-96 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 84% consumer | no trial data cached |
| Gait disturbance | 281 | 3.7 3.3–4.2ROR 3.8 · χ² 556 / p 3e-123 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Balance disorder | 255 | 7.5 6.6–8.4ROR 7.7 · χ² 1,423 / p <1e-300 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Pneumonitis aspiration — n=32, PRR 265.1
- Vagal nerve stimulator implantation — n=23, PRR 212.4
- Aura — n=112, PRR 162.0
- Tonic convulsion — n=29, PRR 53.4
- Thrombocytosis — n=32, PRR 22.3
- Feeling drunk — n=60, PRR 20.5
- Behaviour disorder — n=37, PRR 17.7
- Paradoxical drug reaction — n=25, PRR 17.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Cenobamate ↔ Eosinophilia.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Cenobamate?
In FDA FAERS, the most frequently co-reported reaction terms for Cenobamate are seizure, fatigue, somnolence, dizziness, fall, headache. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Cenobamate have an FDA boxed warning?
No. The FDA label retrieved for Cenobamate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cenobamate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 565c2126-57ae-4e29-b443-723bbe7e2072, effective 20250825; matched on
openfda.generic_name.exact:"CENOBAMATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 806 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.